The present invention relates in general to marking and cutting a heart valve leaflet from a pericardium membrane for use in valve repair/reconstruction, and, more specifically, to devices and systems for simultaneously marking and cutting a valve leaflet with improved accuracy and shortened operating times.
One type of heart surgery relates to heart valve repair or replacement. For a patient with a damaged valve leaflet (e.g., in a bicuspid or tricuspid valve), there is a surgical technique for repairing the valve leaflet using the patient's own pericardium tissue, bovine tissue, or a synthetic material. A man-made synthetic valve has good durability but requires continuous use of an anti-coagulate drug. A valve leaflet reconstruction operation using pericardium tissue removed from the patient is becoming a preferred technique. A thin sheet of pericardium tissue harvested from the patent must be cut and shaped according to the required size of the replaced leaflet. The cut leaflet is then sewn into the original position of the diseased leaflet. This therapy appears to have longer life compared to a bovine tissue valve, and it is generally safe from rejection since this therapy uses the patient's own tissue.
More specifically, the procedure for valve leaflet repair may include the following steps. Circulatory support incisions are made and a perfusion system (i.e., heart lung machine) is connected. The target heart valve (e.g., aortic valve) is then exposed. A thin sheet of pericardium tissue is excised and prepared by treatment with known chemicals. The damaged valve leaflet is trimmed away. A sizing tool is used in order to measure the site (e.g., valve width) to which the new leaflet will be attached. The processed pericardium tissue is placed on a backing plate. Using a template corresponding to the measured size and a marking pen, the desired size and shape for a replacement leaflet is stenciled onto the tissue sheet. The locations (e.g. up to 15 dots) for forming individual sutures may also be marked. Using scissors, the stenciled leaflet is manually cut and trimmed from the tissue sheet. The leaflet is sutured onto the valve annulus and the leaflet commissures are sutured.
During the time that the cut and trim tasks are performed, the heart is stopped and the patient is supported by external circulation using oxygenator and blood pump. This has unfavorable effects on the body, so the duration needs to be minimized. Thus, it would be desirable to minimize valve leaflet preparation time while obtaining more accurately shaped leaflets, thereby contributing to better outcomes of the therapy.